Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
This study is currently recruiting participants.
Verified May 2013 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01669460
First received: August 16, 2012
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue |
Other: Red Bull™ Sugar-Free Drink |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Reduction in overall fatigue as measured by Bruera global fatigue severity scale. [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36) [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
|
Other: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed prostate cancer
- Currently receiving LHRH-agonist therapy for greater than 6 months
- Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
- Able to swallow Red Bull™ Sugar-Free Drink
- Life expectancy of at least 1 year
- Able to read and write in English
- Willing to limit consumption of alcohol to one drink per day
Exclusion Criteria:
- Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
- Myocardial infarction within past 6 months
- Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
- Evidence of drug or alcohol abuse
- Known hypersensitivity to caffeine
- Known history of liver and kidney insufficiencies
- Known contraindications to Red Bull™ use
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669460
Contacts
| Contact: Karen Hersey | 416-946-4501 ext 2155 | karen.hersey@uhn.ca |
Locations
| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5T 1C1 | |
| Contact: Karen Hersey 416-946-4501 ext 2155 karen.hersey@uhn.ca | |
| Principal Investigator: Neil Fleshner, MD, FRCSC, MPH | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Neil Fleshner, MD, FRCSC, MPH | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01669460 History of Changes |
| Other Study ID Numbers: | 12-5041-C |
| Study First Received: | August 16, 2012 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Canada: University Health Network Research Ethics Board |
Additional relevant MeSH terms:
|
Fatigue Prostatic Neoplasms Signs and Symptoms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013